The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Blood Containment Pack.
Device ID | K872448 |
510k Number | K872448 |
Device Name: | BLOOD CONTAINMENT PACK |
Classification | General Surgery Tray |
Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Contact | James E Williams |
Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-23 |
Decision Date | 1987-11-17 |